岗位职责:

1、Write and revise application dossiers of CMC

（chemistry,manufacturing and control)discipline.

2、Review application dossiers of all disciplines inaccordance with regulatory requirements.

3、Assist in application submitting and communicating of various international regulatory markets.

4、Follow up international regulations,guidelines and policies;participate in the interpretation and training of related regulations,and research work of submission strategies.

1、负责药学相关申报资料撰写和修订；

2、按照申报要求，完成各专业申报资料审核；

3、协助完成各个国际法规市场申报提交和沟通；

4、负责跟进国际注册相关指南和法规政策，参与药品往册相关法规的解读、培训，参与各项申报策略相关调研工作。

任职要求:

1、Master

s degree or higher,majoring in Biological/Pharmaceutical/Regulatory Science or relatedfields.

2、Strong foreign language skills,fluent in spoken English,able to comicate conpetently.

3、More than 3 years of Work experience of bio-techmedicinal product R&D in pharmaceutical companies(e.g.purification,analysis etc.,uderstanding ofnonclinical and clinical research).Experience of being responsible for or involved in international application submission is preferred.(Social Recruitment)

4、Good communication and interpersonal skills,and strong writing skills.

1、硕士及以上

生物/药学/监管科学或其他相关专业；

2、较强的外语能力，英语口语流利，能熟练进行沟通；

3、有3年以上在生物企业工作经验，从事过生物产品研发相关技术工作(如纯化、分析等,了解非临床和临床研究)，负责或参与过项目的国际申报者优先(社招)；

4、有良好的沟通和人际交流能力，有较强的文字表达能力。